Despite a range of government reports urging improved transparency, Australia's medical device regulator, the Therapeutic Goods Administration, still fails to help doctors and patients make informed decisions about the safety of medical devices. As highlighted by the recent recalls of metal-on-metal hip replacements and PIP breast implants, medical devices have the potential to do much harm. These recalls have helped to focus attention on two important and frequently neglected issues. The first, how medical devices reach the market. The second, what happens once medical devices are on the market.